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Clinical Trial Summary

The objectives of the present study are to: 1. Evaluate the effect of I-PRF injection following laser gingival depigmentation technique on the healing period as a primary objective. 2. Assess patient satisfaction following the procedure in terms of pain and esthetic outcome as a secondary objective.


Clinical Trial Description

Dental esthetic needs are increasing in recent years with a greater demand on pleasant appearance; including a healthy set of dentitions but also esthetically improved gingival appearance, especially when it is located in the anterior labial region. Physiologic gingival hyperpigmentation affects numerous people of different ethnic backgrounds. Gingival depigmentation is defined as a periodontal plastic surgical procedure that are aimed at removing the pigmented gingiva and methods aimed at masking the pigmented gingiva. Techniques of gingival depigmentation can be classified as; chemical methods mainly by ascorbic acids, surgical methods, electrosurgery, cryosurgery, radiosurgery, and lasers. The study was conducted on eight patients seeking treatment for their gingival hyperpigmentation for esthetic reasons. A total number of 16 sites of facial gingival hyperpigmentation were treated, two in each patient in a split mouth technique. - Group I (LASER with I-PRF): Included eight sites that were treated with laser technique for gingival depigmentation, followed by intramucosal field injection of I-PRF (as study group). - Group II (LASER): Included eight sites that were treated with laser technique for gingival depigmentation (as a control group). The clinical outcomes were assessed for each patient: at baseline (pre-operative), post-operative, one week, one month. Clinical assessment was done by measuring DOPI, clinical wound healing, VAS and patient satisfaction questionnaire. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05283668
Study type Interventional
Source Ain Shams University
Contact
Status Completed
Phase Phase 4
Start date February 20, 2020
Completion date January 30, 2022

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